Ignite Creation Date:
2025-12-24 @ 10:22 PM
Ignite Modification Date:
2025-12-29 @ 3:21 PM
Study NCT ID:
NCT01553435
Status:
UNKNOWN
Last Update Posted:
2015-04-14
First Post:
2012-03-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of N-methyl D-aspartate (NMDA) Receptor Antagonist Dextromethorphan on Opiods Analgesia and Tolerance in Pediatric Intensive Care Unit Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D000377', 'term': 'Agnosia'}], 'ancestors': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D010468', 'term': 'Perceptual Disorders'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003915', 'term': 'Dextromethorphan'}], 'ancestors': [{'id': 'D009019', 'term': 'Morphinans'}, {'id': 'D053610', 'term': 'Opiate Alkaloids'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D006572', 'term': 'Heterocyclic Compounds, Bridged-Ring'}, {'id': 'D006576', 'term': 'Heterocyclic Compounds, 4 or More Rings'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D010616', 'term': 'Phenanthrenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 36}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2011-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-04', 'lastUpdateSubmitDate': '2015-04-12', 'studyFirstSubmitDate': '2012-03-06', 'studyFirstSubmitQcDate': '2012-03-13', 'lastUpdatePostDateStruct': {'date': '2015-04-14', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-03-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Effect of N-methyl D-aspartate (NMDA) receptor antagonist Dextromethorphan on Opiods analgesia and tolerance in Pediatric Intensive Care Unit Patients', 'timeFrame': 'Two years', 'description': 'Control of pain'}], 'secondaryOutcomes': [{'measure': 'Effect of N-methyl D-aspartate (NMDA) receptor antagonist Dextromethorphan on Opiods analgesia and tolerance in Pediatric Intensive Care Unit Patients', 'timeFrame': 'two years', 'description': 'Duration of ventilation in both groups'}, {'measure': 'Effect of N-methyl D-aspartate (NMDA) receptor antagonist Dextromethorphan on Opiods analgesia and tolerance in Pediatric Intensive Care Unit Patients', 'timeFrame': 'Two years', 'description': 'Length of Hospital Stay in two groups'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Dextromethorphan', 'Morphine', 'Fentanyl', 'Opioid', 'analgesia', 'Efficacy'], 'conditions': ['Pain', 'Opioid Tolerance', 'Analgesia Tolerance']}, 'referencesModule': {'references': [{'pmid': '27867308', 'type': 'DERIVED', 'citation': 'Naeem M, Al Alem H, Al Shehri A, Al-Jeraisy M. Effect of N-Methyl-D-Aspartate Receptor Antagonist Dextromethorphan on Opioid Analgesia in Pediatric Intensive Care Unit. Pain Res Manag. 2016;2016:1658172. doi: 10.1155/2016/1658172. Epub 2016 Oct 27.'}]}, 'descriptionModule': {'briefSummary': 'Effect of N-methyl D-aspartate (NMDA) receptor antagonist Dextromethorphan on Opiods analgesia and tolerance in Pediatric Intensive Care Unit Patients'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '14 Years', 'minimumAge': '2 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion:\n\n* Patients above 2 years, admitted in PICU\n* On Morphine or Fentanyl infusions for more than 48 hours\n\nExclusion Criteria:\n\n* Patients under 2 years of age\n* Patients with anticipated PICU length of stay less than 3 days.\n* Patients shall be excluded if Morphine or Fentanyl infusions not continued for the minimum duration of 72 hours after enrollment\n* Patients develops hemodynamic instability\n* Patients with Hepatic failure\n* Withdrawal request by parent(s)/guardian/family'}, 'identificationModule': {'nctId': 'NCT01553435', 'briefTitle': 'Effect of N-methyl D-aspartate (NMDA) Receptor Antagonist Dextromethorphan on Opiods Analgesia and Tolerance in Pediatric Intensive Care Unit Patients', 'organization': {'class': 'OTHER', 'fullName': 'King Abdullah International Medical Research Center'}, 'officialTitle': 'Effect of N-methyl D-aspartate (NMDA) Receptor Antagonist Dextromethorphan on Opiods Analgesia and Tolerance in Pediatric Intensive Care Unit Patients', 'orgStudyIdInfo': {'id': 'RC 09-120'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Dextromethorphan, opioid analgisia, efficacy', 'interventionNames': ['Drug: Dextromethorphan']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo,opioid analgesia, efficacy', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Dextromethorphan', 'type': 'DRUG', 'description': 'The study medicines shall be administered via tube.', 'armGroupLabels': ['Dextromethorphan, opioid analgisia, efficacy']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'The study medicines shall be administered via tube.', 'armGroupLabels': ['Placebo,opioid analgesia, efficacy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11426', 'city': 'Riyadh', 'state': 'Central', 'country': 'Saudi Arabia', 'facility': 'King Abdul Aziz Medical City', 'geoPoint': {'lat': 24.68773, 'lon': 46.72185}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'King Abdullah International Medical Research Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Consultant Pediatric Intensivist', 'investigatorFullName': 'Mohammed Naeem', 'investigatorAffiliation': 'King Abdullah International Medical Research Center'}}}}